High-Intensity Interval Training for Walking and Function Across Different Multiple Sclerosis Disability Levels

NCT07771868 | Recruiting

• 1 other identifier: Hacettepe-PT-MS-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis (MS) is a chronic neurological disease that can affect daily functioning, mobility, and overall quality of life. High-Intensity Interval Training (HIIT) is known to be a time-efficient exercise approach that improves exercise capacity and reduces fatigue in MS. However, current research lacks sufficient data on how HIIT affects individuals with different levels of disability. The main purpose of this study is to evaluate the effects of a stationary bicycle-based HIIT protocol on maximum walking distance, fatigue, balance, muscle strength, endurance, gait speed, and quality of life in MS patients across three different disability levels: mild, moderate, and severe (classified according to Expanded Disability Status Scale - EDSS scores). Participants will complete a cycle ergometer-based HIIT program. Assessments will be conducted at three time points: Before starting the exercise program (baseline) Immediately after completing the program (post-treatment) 4 weeks after the completion of the program (follow-up) To ensure unbiased results, a triple-blind design will be used, meaning the outcome assessor, the treating physiotherapist, and the data analyst will be blinded to group assignments. The findings aim to help clinicians tailor personalized, effective HIIT protocols based on a patient's specific disability level rather than using a standardized, one-size-fits-all approach in MS rehabilitation.

Conditions

MULTIPL SCLEROSİS

Keywords

Multiple Sclerosis; High-Intensity Interval Training; Cycle Ergometer; Expanded Disability Status Scale

Outcome Measures

Primary Outcomes (1)

• Maximum Walking Distance

  Maximum walking distance (in meters) will be objectively estimated using a predictive model previously developed by our research team.

  Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)

Secondary Outcomes (7)

• Fatigue

  Baseline, immediately post-intervention, and 4 weeks follow-up

• Muscle Strength

  Baseline, immediately post-intervention, and 4 weeks follow-up

• Muscular Endurance

  Baseline, immediately post-intervention, and 4 weeks follow-up

• Gait Speed

  Baseline, immediately post-intervention, and 4 weeks follow-up

• Health-Related Quality of Life

  Baseline, immediately post-intervention, and 4 weeks follow-up

Study Arms (3)

Mild Disability Group (EDSS 0 to <=2.5)

EXPERIMENTAL

Behavioral: High-Intensity Interval Training

Moderate Disability Group (EDSS 3.0 to <=4.5)

EXPERIMENTAL

Behavioral: High-Intensity Interval Training

Severe Disability Group (EDSS 5.0 to <=6.5)

EXPERIMENTAL

Behavioral: High-Intensity Interval Training

Interventions

High-Intensity Interval Training BEHAVIORAL

All exercise sessions in our study will be conducted using a bicycle ergometer (Monark Cardio Care 827 X, Monark Exercise AB, Sweden). The HIIT protocol will consist of five 3-minute high-intensity intervals performed at 80-100 revolutions per minute, corresponding to 85-90% of maximum heart rate. Between these intervals, active rest periods will be implemented, during which cadence is reduced to 50-60 revolutions per minute for 1.5 minutes to lower heart rate to 50-60% of maximum heart rate. The total training duration is planned to be 20 minutes, consisting of a 2-minute warm-up at the beginning and a 2-minute cool-down at the end. Sessions will be conducted three times a week. The total treatment duration is planned to be 8 weeks.

Mild Disability Group (EDSS 0 to <=2.5); Moderate Disability Group (EDSS 3.0 to <=4.5); Severe Disability Group (EDSS 5.0 to <=6.5)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 18 and 65,
• Have been diagnosed with MS by a treating physician,
• Have an EDSS score between 0 and 6.5,
• Not having experienced a relapse within the last 3 months,
• Not having severe lower extremity contractures, severe spasticity (≥3 on the Modified Ashworth Scale), or an acute orthopedic problem that would prevent the participant from pedaling on a bicycle ergometer,
• Having a Mini Mental State Examination score of ≥24.

You may not qualify if:

• Having a severe cardiovascular, orthopedic, respiratory, or metabolic disease,
• Having an additional neurological condition,
• Being pregnant or suspecting pregnancy,
• Having received a botulinum toxin injection within the last 3 months,
• Having a COMPASS-31 total score greater than 13.6

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hatay Mustafa Kemal Universty

Hatay, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

İSMAİL KARA, MSc

CONTACT

+90 553 525 8700; ismailkaraa46@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)